CN104619330B - The preparation comprising hypochlorite and amino acid for treat wound and sore - Google Patents
The preparation comprising hypochlorite and amino acid for treat wound and sore Download PDFInfo
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- CN104619330B CN104619330B CN201380039773.4A CN201380039773A CN104619330B CN 104619330 B CN104619330 B CN 104619330B CN 201380039773 A CN201380039773 A CN 201380039773A CN 104619330 B CN104619330 B CN 104619330B
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- HRDXJKGNWSUIBT-UHFFFAOYSA-N methoxybenzene Chemical group [CH2]OC1=CC=CC=C1 HRDXJKGNWSUIBT-UHFFFAOYSA-N 0.000 description 1
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- 239000011734 sodium Substances 0.000 description 1
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- HPALAKNZSZLMCH-UHFFFAOYSA-M sodium;chloride;hydrate Chemical compound O.[Na+].[Cl-] HPALAKNZSZLMCH-UHFFFAOYSA-M 0.000 description 1
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- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical class NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/16—Otologicals
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Landscapes
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- Dermatology (AREA)
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- Oncology (AREA)
- Pain & Pain Management (AREA)
- Communicable Diseases (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
In the kit for preventing and/or treating sore, being used in wound, ulcer and similar conditions or fistula or otitis.The kit includes the first aqueous components and the second aqueous components, first aqueous components include one or more amino acid, second aqueous components include the halogen compounds of activity, wherein, the pH of first component and/or second component is about 9 to 11.5.Present invention also offers the treatment preparation prepared by the component and the treatment preparation to prevent and/or treat sore, the use in wound, ulcer and similar conditions or fistula or otitis.
Description
Technical field
The present invention relates to used in prevention and/or treatment sore, wound, ulcer and similar conditions or fistula or otitis
Kit (a kit of parts) and preparation.Moreover, it relates to the method using the kit and preparation.
Background technology
Sore and wound, such as chronic wounds are common and make patient by pain, make to turn into society in terms of expense
Burden (see Serens T, Bates-Jensen B, Carter MJ, Cordrey R, Driver V, Fife CE, etc..
Consensus principles for wound care research obtained using Delphi process。
Wound repair and regeneration.In May, 2012；20(3)：284-93).
For example, as it is known that the method for being used to treat sore and wound include being cleared up with water.Antiseptic and antibiotic also usual quilt
For preventing and treating the infection of such as skin sore or skin ulcer.Skin ulcer be where at the sore decomposed of tissue and
Skin ulcer can cause epidermis, corium even subcutaneous tissue injury.Skin sore, especially skin ulcer, hence it may becomes difficult to treat
And long-term treatment may be needed.Therefore, the treatment includes reducing the risk of infection and inflammation, and keeps for sore
Environment.Local antiseptic and antibiotic is already used at least reduce the risk of infection.
Chlorine compound, such as hypochlorous acid and toluene-sodium-sulfonchloramide are because they have been studied as the function of antiseptic.Knownization
One problem of compound is, they are probably to have aggressive and poisonous to living tissue, and they are usually unstable
Material, therefore the decomposition of undesirable material can be caused, for example, the inactivation of the material.
Antiseptic solution containing N- chlorotaurines, which has also been asserted, can be used to use for treatment infection and control inflammation
(Waldemar Gottardi and Markus NagI, N-chlorotaurine, a natural antiseptic with
Outstanding tolerability, J Antimicrob Chemother 2010；65：399-409).N- chlorotaurines
It is the N- chlorinated derivatives of taurine.In the article, N- chlorotaurines are carried as natural, long-acting oxidant
And and its provide it is compromise between enough antibacterial activities and tissue tolerance.Also it is noted, for treating skin
The use of the antiseptic solution comprising N- chlorotaurines of ulcer infection.
Although the material of prior art can alleviate prevention and treatment skin sore, wound, ulcer and class to a certain extent
Like the problem of illness, but still it is highly desirable be used for improve and/or replacement material or preparation, they at least with it is known
, material for described prevention or treatment or preparation be interchangeable.
The content of the invention
In view of material that is known, being used in skin wound is treated, for example, purpose is to provide with hypotoxicity and good
Improvement and/or replacement the preparation of stability, the preparation can be used for preventing or treat sore, wound, ulcer and its similar disease
Disease.
The purpose is by the kit according to appended claim 1, the treatment according to appended claim 19
Preparation, the use according to appended claim 24 and the method according to appended claim 29 are by completely or partially
Realize.Embodiment is set forth in appended dependent claims and the description below and example.
According on one side, there is provided herein preventing and/or treating sore, wound, ulcer and its similar conditions or fistula
The kit used in pipe or otitis.The kit includes：
A) the first aqueous components, first aqueous components include one or more amino acid, and
B) the second aqueous components, second aqueous components include the halogen compounds of activity.
The pH of first component and/or second component is about 9 to 11.5.
Term " active halogen compounds " herein refers to the secondary halogen of ion, gas, the halogen of salt form or halogen
Hydrochlorate.
Two kinds of described components are used to mix, and are used to be coated to controlling for therapentic part (such as ulcer) so as to be formed
Treat preparation.The treatment preparation has been shown that in treatment sore, ulcer, wound, burn and fistula be useful, and slow
Property and infect, under downright bad situation be also useful.The treatment preparation is tested the object with otitis, its
In, the treatment preparation is asserted available for treatment otitis (data are not shown).Therefore, the treatment preparation is also expected to treating
Help is provided in otitis.It is also shown as being used as antiseptic and for preventing infection or inflammation.The treatment preparation pair
It is effective in treating different types of therapentic part (such as chronic sore, ulcer, bedsore, blood vessel sore and chronic diabetic ulcer)
's.The treatment preparation also provides method for decomposing the part at sore or similar illness, is decomposed for example, described
Part can be bacterium, purulence, the cell of necrosis or the scab being present at sore or similar conditions.
The first described component reduces the halogen compounds of activity to living tissue aggressiveness.Formed by two kinds of components
Treatment preparation include one or more amino acid, the amino acid be in use it is useful and provide it is less aggressive and
The method of toxicity is used to treat sore and similar conditions.Two kinds of liquid components are utilized using the treatment of the treatment preparation, when described
When two kinds of liquid components are combined to be treatment preparation and are applied to therapentic part, cause chemical reaction, the chemical reaction
It is considered as generating the primary halogenated amine of (primary) halogenated amino acid form, such as primary chloro-amino-acid.For primary chloro-amino-acid,
Refer to the amino acid with a chlorine atom on amino.Treatment disclosed herein is considered as utilizing this chemical reaction.So
Place, the chemical reaction for producing primary halogenated amino acid is referred to as the first reaction.
Application of the use of chloramines as be known in the art dependent on the reaction after the first described reaction, and
In the reaction, the preparation should have low pH, it is, being just below the pH (such as pH is about 6) of neutrality.After these
Continuous reaction generation dihalo amine, that is to say, that the nitrogen-atoms in amine carries two chlorine atoms.PH is usually less than neutral pH,
, with the treatment using treatment preparation disclosed herein on the contrary, in treatment preparation disclosed herein, the pH is higher simultaneously for this
And it is alkalescence.It is thus known that the method using chloramines as antiseptic do not have using under ph basic conditions first reaction,
The reaction that dichlormaine is formed such as under the conditions of acid pH (such as pH is about 6) is make use of on the contrary.
It is thought that high pH is provided for occurring in therapentic part, the required reaction that produces primary halogenated amino acid herein
Method, while analgesic and the aggressiveness to living tissue minimum are also provided.
The treatment preparation formed, which has been shown, provides treatment, and in the treatment, object is during treatment and treats
The pain being subjected to afterwards is reduced, or is even eliminated.At least, the treatment preparation will not be provided object any additional
Pain.
In addition, the use of the treatment preparation provides and reduces what is generally come out from the sore of infection, wound or ulcer
The possibility of stench.
The kit is divided into two parts and provides holding component stability and in the treatment system prepared to object coating
The path of the wherein risk of ingredient breakdown is reduced before agent.Occur in addition, the regulation of kit provides reaction needed for control
The method of the therapentic part.
The component also has minor impact after being mixed to environment, because the component of mixing will substantially divide
Solve as salt, gas and water.The fact that should be noted is the concentration of the halogen (such as chlorine) used in the component and treatment preparation
Amount less than the chlorine used in water chlorination purified water or the amount less than the chlorine used in chloride home bleaching products.
According to embodiment, the pH of the first component and/or the second component can be about 9 to 11 or about 9.5 to
11.5, or about 10 to 11.5, or about 10.5 to 11.5, or about 11 to 11.5, or about 9 to 10.5, or about 9.5 to 10.5.
The prevention and/or treatment can include analgesic effect.Surprisingly, the treatment preparation is had shown that with this
Kind effect.
As indicated above, the treatment preparation can also have antibacterial effect.The treatment preparation can for following bacteriums
It is useful：Streptococcus (streptococcus, such as MRSA), staphylococcus (staphylococcus), pseudomonad
(pseudomonas), actinomyces (Actino mycetes) and Escherichia coli (E.coli), super wide spectrum beta-lactam is especially produced
The E.coli of enzyme (ESBL).
Any use that can reduce antibiotic has been shown in the treatment preparation, and in one embodiment,
Through being not necessarily to using antibiotic to treat the therapentic part of infection.Even show using the treatment preparation without using antibiosis
The treatment of element is than using the treatment preparation and more efficient using the treatment of antibiotic.
According to embodiment, described sore, ulcer, fistula or otitis are chronic, and comprising inflammation, infection and/or
Necrosis.
By by the component be mixed to get treatment preparation it is as described herein for the use at chronic position in
It is shown to be useful, other known treatment has been shown to be unsuccessful.
According to embodiment, described use is that non-oral formula uses.
From disclosure herein disclosed it is clear that by the treatment preparation that is mixed to get the first component and the second component
Through surprisingly showing that in preventing and/or treating non-mouth therapentic part (such as skin sore, wound and ulcer) be useful
's.The example of skin sore, skin wound and skin ulcer is diabetes sore (diabetic foot sore), infectious occipital bone
The ulcer of portion's sore, infective ulcer and leg and/or foot, amputation wounds and infectious burn.In addition, the treatment
Preparation can be used to treat fistula (such as anal fistula) and otitis.
According to embodiment, the active halogen compounds can be the chlorine compound of activity.
According to embodiment, the active chlorine compound can be Cl2, chloride, hypochlorite, chlorite, chlorine
Hydrochlorate, perchlorate and/or hypochlorite compounds.
The ionic compound can be the form of sodium, calcium, lithium and/or potassium, for example, hypochlorite compounds can be time
Sodium chlorate, calcium hypochlorite, lithium hypochlorite and/or postassium hypochlorite.
According to embodiment, the amount of the active halogen compounds in the second component can be by weight 0.5%-5%,
0.5%-3% or 1%-2%.
Unless otherwise stated, percentage by weight as described herein is meant that compound or the weight of its similar substance
Relative to the gross weight of the similar substance of mentioned compound or inclusion compound.
Treatment using the treatment preparation with these concentration is effective, and 1%-2% concentration (by weight)
Seem especially effectively, any side effect will not be caused.
As used herein, amino acid is by amine (- NH2) and carboxylic acid (- COOH) functional group and for every monoamino-acid
Organic compound made from specific side chain.
According to embodiment, one or more amino acid can be selected from：Alanine, arginine, asparagine, asparagus fern
Propylhomoserin, glutamic acid, glutamine, isoleucine, leucine, lysine and/or valine.
These amino acid have been identified the species that can form primary halogenated amino acid (such as primary chloro-amino-acid).Institute
The pK values and property for stating side chain are that primary halogenated amino acid can be formed, and are caused using the amino acid to object side effect
Low risk (if side effect).
Especially, one or more amino acid can include glutamic acid, leucine and lysine or by glutamic acid, bright ammonia
Acid and lysine composition.
These amino acid have been shown to be useful in this paper use.
According to embodiment, the first component can include 0.1%-1% (by weight) described one or more ammonia
Base acid.
In embodiments, the concentration of the amino acid in the first component can be that 0.4%-1.0% or 0.5%-1% (are pressed
Weight meter), or 0.4%-0.8% or 0.5%-0.8% (by weight).Described amino acid composition can include amino
The mixture of acid, the amino acid is according to the weight ratio about 2 between every kind of amino acid:1 to 1:2, preferably about 1:1 relation quilt
Mixing.
According to embodiment, described two components are used for volume ratio 1:2 to 2:1, preferably about 1:1 is blended in one
Rise, so as to be formed for being coated to therapentic part i.e. sore, wound, ulcer or the treatment of similar illness or fistula or otitis
Preparation.It is described in 30 seconds after the component is mixed together under room temperature (20 DEG C) and 1atm air pressure (101325Pa)
Treat preparation have about 9 to 11.5 or about 9 to 11 or about 9.5 to 11.5 or about 10 to 11.5 or about 10.5 to 11.5 or
About 11 to 11.5 or about 9 to 10.5 or about 9.5 to 10.5 pH.
By this way, there is provided the reaction for ensureing to generate primary halogenated amino acid has appropriate reaction condition, to send out
The raw method in therapentic part as described herein.Therefore, kit is divided into the reaction that two parts are provided needed for control and occurred
In the mode of the therapentic part.
Described use is possibly comprised in before bubble occurs in treatment preparation or applied during bubble occurs in treatment preparation
The treatment preparation.If the chlorine compound of activity is used, the smell of chlorine can also occur with the formation of bubble.With this
Mode, suitable reactions are guaranteed.
According to an embodiment, the first described aqueous components can further include colloidal substance.
The colloidal substance provides the mode for keeping moist to keep moist environment for therapentic part, and especially
Ground, when the preparation is applied on therapentic part, described colloidal substance is reduced from the first component and the second component
The evaporation of obtained water-based treatment preparation.In addition, the colloidal substance is also suitable to treating preparation offer as made from two kinds of components
When denseness.
Treatment preparation containing colloidal substance and with " high " alkaline pH provides effective pre- for as described above
Anti- or treatment purposes, while provide the low aggressiveness to therapentic part.Seem during treatment and after treatment, institute
Any pain will not also be caused by stating treatment preparation.
Described colloidal substance can include or polyethylene glycol (PEG), and/or carboxymethyl cellulose and/or more
Sugar substance or its salt, such as sodium carboxymethylcellulose (Na-CMC).
This material provides described denseness and serves as the material for keeping moist, prevents from described treatment preparation
With the evaporation of therapentic part.
According to embodiment, first component can include 2%-4% (by weight) colloidal substance.
According to embodiment, first component may also include NaCl.
NaCl addition adds the active chlorine compound being present in first component and the treatment preparation
Content.NaCl equally also has antibacterial effect.
Described component can be with trade markWithThe production that (RLS Global AB) is sold
Product.
According to embodiment, the kit can also include third component fat shape creme.
The fatty shape creme can beZinc ointment or the like.It is used for along sore, wound and/or
The edge of ulcer is coated, and then applies applying treatment preparation.The method that the use of the fatty shape creme provides closure, so as to
The required therapentic part that then the treatment preparation that is applied on therapentic part (such as sore) can be with object is in contact, and
And it is maintained at herein during treatment.Therefore, described fatty shape creme can ensure that fluid preparation is retained at sore, without
The skin area flowed away at sore around sore.
According to an embodiment, the kit may also include the 4th component protection preparation.
The protection preparation is used to be coated among the treatment using preparation of the present invention and after treatment, so as to
Therapentic part is protected, also for the healing of stimulation therapy position (such as sore or wound).
The protection preparation can include vitamin D, to improve immune defense and agglutination, because vitamin
D is expected and known has stimulation.In addition, the protection preparation can also include vitamin A, to be provided for vitamin D
The method for reaching the position, as known in the art, to improve immune defense.Therefore, vitamin A and vitamin D can be by
For allowing to stimulate immune defense system and strengthening agglutination.
The protection preparation can be creme or colloid substances.The protection preparation can be well known to those skilled in the art
Alcogel or the glycerinated colloid substances of bag.The example of this protection preparation is i) to contain vitamin D, and alternatively vitamin A
Mano+ (coming from RLS Global AB companies)；And ii) come from Janssen-Cilag AB companies with trade mark
The colloid substances or creme containing vitamin A that Aberela is sold, vitamin D can be added into the colloid substances or creme.
The protection preparation is coated on the therapentic part (i.e. sore, wound, ulcer and similar conditions), wherein, it is described
Preparation cover the therapentic part.Alcogel or the like will provide for protective layer, and the protective layer is after alcohol evaporation
Formed.
The protection preparation is coated after the treatment using the preparation of two kinds of components and among treatment, and preferably
It is coated after one or many treatments are carried out, and when not infecting or almost not infecting in therapentic part, and
When granulation tissue is visible, the surface of therapentic part (such as sore) flushes with the health tissues around therapentic part (such as skin).
According on one side, there is provided preventing and/or treating sore, wound, ulcer or similar conditions or fistula or otitis
The middle treatment preparation used, wherein, the treatment preparation be by by the first component as described above and the second component according to
Volume ratio 1:2 to 2:1, preferably according to volume ratio about 1:1 mixing obtains.
For example, desired effect has been shown in this treatment preparation in use as described above.
According to an embodiment, (under room temperature and 1atm pressure (101325Pa)), one is blended in the component
In 30 seconds after rising, the treatment preparation has about 9 to 11.5 pH.The pH can be about 9 to 11 or about 9 to 10.5 or
About 9.5 to 10.5 or about 9.5 to 11.5 or about 10 to 11.5 or about 10.5 to 11.5 or about 11 to 11.5.
This is provided for causing appropriate reaction that the mode on therapentic part occurs, while is provided all above-mentioned
The advantages of.
As described above, the use for the treatment of preparation may be embodied in before bubble occurs in treatment preparation or occur in treatment preparation
The treatment preparation is applied during bubble.If the chlorine compound of activity is used, the smell of chlorine also can be with the shape of bubble
Into appearance.In this way it is assured that the generation suitably reacted.
According to embodiment, described prevention and/or treatment can include analgesic effect, described sore, ulcer, fistula or
Otitis is chronic and comprising inflammation, infection and/or necrosis.Used in addition, described use can be parenteral formula.
According on one side, there is provided treatment preparation as described above is preventing and/or treating sore, wound, ulcer or similar
Use in illness or fistula or the production of the medicine of otitis.
It is described treatment preparation the embodiment used, hereinbefore from prevent and/or treat sore, wound, ulcer or
In similar conditions or fistula or otitis using treatment preparation for the use of be mentioned.
According on one side, there is provided prevent and/or treat therapentic part (i.e. sore, wound, ulcer or similar conditions,
Or fistula or otitis) in the method that uses.
Methods described includes：
A) above-described treatment preparation is coated on the therapentic part of object to be treated, the treatment preparation bag
Containing the first component and the second component of active halogen compounds with one or more amino acid；
B) cultivate the treatment preparation that is coated in step a), so as to allow to treat preparation therapentic part is worked and/
Or allow to treat the part that preparation decomposition is present in therapentic part；
C) treatment site removes treatment preparation and the part being decomposed；And
D) alternatively, repeat step a to step c.
According to embodiment, as long as occurring bubble in treatment preparation, the treatment preparation in step b) can be allowed to always
Culture.If the chlorine compound of activity is used, the smell of chlorine can also occur with the formation of bubble.Finally, preparation is treated
In chlorine smell and bubble collapse, now stop culture.
According to embodiment, the treatment preparation in step b) can be cultured about 30 seconds to 10 minutes, preferably about 30
Second to 5 minutes.
According to embodiment, step c), which can include, is rinsed or is cleared up therapy section using water, physiological saline or the like
Position.
In most cases, water may be used, because after step b), NaCl will appear in therapy section
Position.
Dry compress or protection pad (pad), or the compress or protection pad that are soaked by water, physiological saline or the like also may be used
It can be used to clear up therapentic part and remove any part being decomposed at this.Compress comprising silica or activated carbon or
Protection pad can also be used for effective cleaning and/or remove excessive fluid and the part being decomposed.Compress or protection pad can be with
It is used to cover therapentic part among the treatment using treatment preparation of the present invention or after treatment, to carry for healing
For appropriate environment.
According to embodiment, step c) includes bacteria removal, purulence, and/or the part of necrosis.
Fatty shape creme as described above can be before step a) along by the side of the sore of the treatment preparation coating
Edge is coated.This is that position to be treated or region (such as sore) provide barrier, so that the treatment preparation being coated can
It is in contact with the required body part of object, and is maintained at herein during treatment.Therefore, the fatty shape creme
The fluid preparation that can ensure then to be applied at sore is retained at sore, rather than the skin flowed away at sore around sore
Skin region.
According to embodiment, the therapentic part can step d) below the step of in by protection system as described above
Agent is covered.
The treatment preparation can shortly before step a), by mixing the first component and the second component to prepare,
To allow the treatment preparation and appropriate treatment described above and reaction condition now matched somebody with somebody.
Methods described may be embodied in before bubble occurs in treatment preparation or apply institute during bubble occurs in treatment preparation
State treatment preparation (step a).If the chlorine compound of activity is used, the smell of chlorine can also occur with the formation of bubble.
In this way it is assured that the generation of appropriate reaction.
According to an embodiment, the treatment preparation is by the way that the first component and the second component are mixed before step a)
Close and be produced, and step a) be in two minutes after the component is mixed together, more preferably in 1 minute,
Occur in 45 seconds or in 30 seconds.
According to embodiment, described prevention and/or treatment in the method can include analgesic effect, and described
Sore, ulcer, fistula or otitis are chronic and comprising inflammation, infection and/or necrosis.In addition, described use can be non-mouth
The style of dress uses.
The present invention is described more fully now with reference to embodiment, picture and embodiment.
Brief description of the drawings
Fig. 1 shows the photo of the ulcer before any treatment using the treatment preparation according to the present invention.
Fig. 2 shows photo of Fig. 1 ulcer after the treatment using the treatment preparation according to the present invention.
Embodiment
Sore and wound, such as chronic wounds and ulcer are common and make patient by extremely heavy pain and work(
Energy obstacle burden, while also make society by financial burden (Serens T, Bates-Jensen B, Carter MJ, Cordrey
R, Driver V, Fife CE etc..Consensus principles for wound care research obtained
using Delphi process.Wound repair and regeneration.In May, 2012；20(3)：284-93).
The method of known treatment chronic wounds and ulcer includes cleaning number weekly with the solution of water or such as physiological saline
It is secondary, and among cleaning with it is some species of it is active, be usually antibacterial dressing (such asSilver,Iodide and) apply and bind up a wound.
The cost of cleaning treatment is sizable, also, for example needs nursing staff to work a few hours.By clearing up and applying
The treatment effect of wrapping is applied according to healing, the reduction of wound size and the mitigation of pain, the development of wound or ulcer, wound and is burst
How long ulcer is cleaned once, how long consuming is treated in a few weeks or months, is weighed using the demand of antibiotic.Relevant wound
Mouth and the Therapy study of ulcer seldom reach healing endpoint.
Inflammation is as caused by local infection and/or tissue damaged.The typical sign of local infection is pain, heating, swollen
Swollen, general red and afunction.However, the patient of chronic wounds often suffers from suppressing the complication of signs of inflammation.Therefore, identification is slow
Property wound infection be probably difficult and need to rely on other S＆Ss.Chronic wounds are, for example, diabetic foot
Ulcer, venous leg ulcers, lower limb/sufficient arterial ulcer and pressure ulcer.Infection can be determined by following：a)
Pain that is new, increased or changing, b) delay healing or the healing gone no further, c) wound circumference oedema, d) bleeding or
Fragile granulation tissue, e) special stench or change smell, f) wound surface discoloration, g) it is increased, changing or suppurate
Exudate, g) scleroma, h) chamber groove (pocketing) or put up a bridge (bridging).In addition, the sense for the chronic infection that localizes
Contaminating propagation may be by following identified：I) wound festers, j) from edge of wound sprawling erythema, k) spread to wound circumference area
The crepitus in domain, warm, the scleroma of discoloration, and/or l) sense of discomfort of the usual state of patient or non-specificity deteriorate (see World
Union of Wound Healing Societies(WUWHS)Principles of best practice。Wound
infection in clinical practice。An international consensus。London MEP Ltd
2008.It can be obtained from www.woundsinternational.com websites).
As described above, antiseptic and antibiotic are normally used for controlling for sore and wound (such as chronic wounds or ulcer)
Treat.Above it is mentioned that for example, the solution containing N- chlorine taurines, which is also noted in the treatment for skin ulcer, is used as antibacterial
Agent (Waldemar Gottardi and Markus Nagl, N-chlorotaurine, a natural antiseptic with
Outstanding tolerability, J Antimicrob Chemother 2010；65：399-409).
In the summary about ulcer, different component and material (such as aloe, brine spray, the chlorination of saliferous are tested
Silver and decyl glucoside) treatment ulcer ability.Draw the following conclusions that " few experimental evidences are supported to burst for repressive
Ulcer clears up solution or technology and the shortage of evidence using the wound of any specific should cause the pass of health care provider
Note " (Moore Z, Cowman S.A systematic review of wound cleansing for pressure
ulcers.J Clin Nurs, 2,008 17 (15)：1963-72).
Therefore, it is necessary to probe into the preparation of the new treatment for being used for sore, wound, ulcer or similar conditions, the preparation carries
Supply while various sores, wound and ulcer is treated, it is friendly to body part (such as the skin being in contact with the preparation)
Possibility, and the preparation can reduce patient as described above and society burden.
Kit the present invention relates to the new purposes for the treatment of preparation and for preparing treatment preparation, it is directed to the side for the treatment of
Method, above-mentioned application, kit and treatment method for it is mentioned above overcome described problem in terms of be found to be it is useful.Institute
State purposes and method is related to the treatment of sore, wound, ulcer, fistula or otitis.Method
Hereinafter, the present invention will be by for preventing and/or treating for example with inflammation, infection, suppuration and/or necrosis
Burn, chronic wounds and ulcer and the method for fistula or otitis be illustrated.Fistula can be anal fistula, and the anal fistula is
The abnormal path of skin surface is extended to from rectum.
Method and treatment preparation used herein provides analgesic effect, while also provides antibacterial effect, and can use
In prevention and/or treatment sore, ulcer, fistula or otitis, especially used with parenteral formula, the sore, ulcer, fistula or otitis
It is chronic and comprising inflammation, infection and/or necrosis.
Generally, the described method comprises the following steps：
- treatment preparation described herein is coated on therapentic part (such as sore, fistula, otitis or its similar conditions),
The treatment preparation includes second group of the first component and active halogen compounds with one or more amino acid
Point；
The treatment preparation being coated in-culture above-mentioned steps, to allow the treatment preparation to work therapentic part
With the part for allowing treatment preparation decomposition to be present in therapentic part；
- treatment preparation and/or the part being decomposed are removed from object；And
- alternatively, repeat the above steps.
Method described herein is useful in for such as treatment skin wound or ulcer, wherein bacterium, purulence, bad be present
Dead cell and/or the part of scab, wherein the part can be eliminated or be reduced by this method.
As described above, this method also provides the mode for analgesic, while provides the effect of antibacterial, wherein,
Therapentic part bacterium (such as streptococcus, staphylococcus, pseudomonad, actinomyces and Escherichia coli (E.coli), it is especially anti-
The E.coli of the generation extended spectrumβ-lactamase (ESBL) of Multiple Classes of Antibiotics) quantity can be reduced in addition eliminate.
In addition, the use of described treatment preparation provides the mode for reducing stench, the stench is generally risen in
Infected sore, wound or ulcer.
Controlled by the way that the first component and the second component are mixed (under room temperature and 1atm pressure (101325Pa)) described in preparation
Treat in 30 seconds after preparation, the treatment preparation has about 9 to 11.5 pH.When being coated on sore or similar conditions, this is carried
For " high " alkaline pH.Under such pH, it is described treatment preparation be effective for use as described herein, while with
The treatment preparation known is compared, and has less aggressiveness to living tissue.As described herein, the treatment preparation even provides pain
Control and pain weaken.In addition, as this paper is described further below, high pH also ensures desired, formation halogenated amino acid
The reaction of (such as primary chloro-amino-acid) occurs in described therapentic part.
According to embodiment, it is described treatment preparation pH be about 9 to 11,9 to 10.5 or 9.5 to 10.5 or about 9.5 to
11.5 or about 10 to 11.5 or about 10.5 to 11.5 or about 11 to 11.5.
Therefore, the treatment preparation can be by by the first aqueous components including one or more amino acid and including work
Property halogen compounds the second aqueous components mixing and be made.
The active halogen compounds can be above-described any compound, for example, hypochlorite chemical combination
Thing (such as sodium hypochlorite), the hypochlorite compounds can be with 0.5%-5%, 0.5%-3% or 1%-2% (by weight
Meter) content be present in second component.Minimum content 0.5%-3%, particularly 1%-2%, have been illustrated enough
For therapeutic purposes as described herein.First component can include described one or more amino acid, and the amino acid contains
Measure as 0.1%-1% (by weight), or other any concentration as described herein.Wherein, between the amino acid
Using weight ratio as about 2:1 to 1:2, preferably with 1:1 relation is present.First component and the second component all have, for example, using
About 9 to 11.5 pH of NaOH regulations.In embodiments, the pH is about 9 to 11,9 to 10.5 or 9.5 to 10.5 or about
9.5 to 11.5 or about 10 to 11.5 or about 10.5 to 11.5 or about 11 to 11.5.
Two kinds of described components can be using volume ratio as 1:2 to 2:1, preferably about 1:1 is mixed, described so as to be formed
The treatment preparation to be coated on therapentic part (such as wound).Preferably, described two components apply by treatment preparation
It is mixed shortly before on to therapentic part.It reduce the risk that the active component in treatment preparation is decomposed, so as to desired
, reaction that form primary halogenated amino acid occurs during treatment, by cultivating the treatment preparation of therapentic part.Therefore, originally
Text is provided in the coating of the treatment preparation, there is provided the method for the treatment preparation including active component.By that will apply
Component is mixed before the treatment preparation, the pH of the treatment preparation is pH as described above, so as to ensure that the excellent of it
Point.
It is described treatment preparation can shortly before it is coated, by the way that the first component and the second component are mixed with,
To allow the treatment preparation and appropriate treatment and reaction condition described above now matched somebody with somebody.
The treatment preparation may be embodied in before bubble occurs in treatment preparation or be applied during bubble occurs in treatment preparation
Apply the treatment preparation.If the chlorine compound of activity is used, the smell of chlorine also can be with bubble formation.By with this side
Formula, appropriate reaction are guaranteed.
According to an embodiment, the treatment preparation is by be made, then the first component and the second component are mixed
The reagent is applied in 2 minutes after the component is mixed, in preferably 1 minute, in 45 seconds or in 30 seconds.
First component can also include colloidal substance, the colloidal substance content 2%-4% by weight.
The colloidal substance can be the salt of PEG, and/or carboxymethyl cellulose and/or polysaccharide material or above-mentioned each material
(such as sodium carboxymethylcellulose (Na-CMC)).In one embodiment, the colloidal substance can be highly viscous carboxylic first
Base cellulose gel.The high viscosity of carboxymethyl cellulose is defined as 800-1300 (mPas；Room temperature).The colloidal substance can also
It is moderately viscous carboxymethyl cellulose, the medium-viscosity of carboxymethyl cellulose is defined as 400-800 (mPas).The colloid substances
Matter provides the mode for keeping moist to keep moist environment for therapentic part, wherein preventing treatment preparation and therapentic part
Evaporation.In addition, the colloidal substance also provides appropriate denseness to treat preparation as made from two kinds of components.
Coating treatment preparation with colloidal substance with the pH and alternatively, is expected to provide according to as described herein
The effect used.
According to embodiment, described one or more amino acid can be selected from：Alanine, arginine, asparagine, day
Winter propylhomoserin, glutamic acid, glutamine, isoleucine, leucine, lysine and/or valine.
These amino acid have been identified the species that can form primary halogenated amino acid.The pK values and property of side chain cause
Primary halogenated amino acid can be formed, also, it uses the low-risk for also causing the side effect (if any) to object.
Especially, one or more amino acid can include or are made up of glutamic acid, leucine and lysine, because this
A little amino acid have been illustrated to be useful for as described herein use.
Second component may also include one or more following compounds：Sodium chloride, titanium oxide, EDTA and sodium hydroxide.
It thus provides therapentic part (such as sore, ulcer or its similar illness or fistula (such as anus can be applied to
Fistula)) on fluid preparation, the treatment preparation can work as coating with fluid, the preferably denseness with liquid gel
When, the treatment preparation can be automatically spread on the surface of sore, ulcer or its similar conditions so that the surface is completely covered.
The treatment preparation can also be injected into position to be treated (such as fistula).
Can be with trade mark for the component used according to the present invention and preparationWith(RLS
Global AB) sell product in a kind of product.
In table 1 below, there is provided as described for treating two kinds of components of a part for the kit of preparation for carrying
The example of content.The content largely with trade markWithThe component and system of sale
Agent is consistent.
* the total amount of amino acid, the amino acid is with weight ratio about 1:1:1 relation is present.
Based on for preventing or treating the use of the aqueous formulation of the therapentic part, the therapentic part is methods described
Sore, wound, ulcer or similar conditions or fistula (such as anal fistula) or otitis.
Methods described includes treatment preparation being coated on therapentic part, makes the culture for the treatment of preparation for a period of time, to make
Obtain for example, in a subsequent step, removing the part that is decomposed (such as cell of necrosis) and providing the infection risk of reduction.
The coating of the treatment preparation is preferably carried out, so as in the halogen compounds and described one kind or more of activity
Part or all of first reaction of the primary halogenated amine of generation (such as chloro-amino-acid) between kind amino acid, in described treatment
Position occurs.This be by mutually being mixed in the first component and the second component shortly after, that is to say, that in two kinds of described groups
In 2 minutes after point being mixed, in preferably 1 minute or (such as in 5 seconds to 10 seconds) coating in more preferably several seconds
What the treatment preparation was realized.Then it is described treatment preparation when being coated on therapentic part with alkalescence pH, e.g., from about 9 to
About 11.5 pH value.High pH provides the condition for the first reaction to occur, while the treatment preparation also provides analgesic
Effect.
The reaction that the use of chloramines as be known in the art is depended on after the described first reaction, and the preparation
Should have than according to the low pH of herein described aspects and embodiment.The pH is usually less than neutral pH, this and herein
Described treatment is opposite, and in treatment as described herein, pH is alkalescence.It is thus known that use chloramines as antiseptic
Method not using the first reaction, on the contrary make use of the reaction for such as forming dichlormaine occurred in the stage more rearward
Reaction.
It is coated to by treatment preparation in the embodiment of therapentic part, methods described, which can be included in, applies applying treatment preparation
Before, along edge coating fat creme of sore, wound or ulcer or the like (fatty shape creme).The use of fatty creme is true
Protect the subsequent fluid preparation for being coated to sore, wound or ulcer to be maintained at sore, wound or ulcer, rather than flowed away into from that
Skin area around sore, wound or ulcer.
The fatty creme can beOr zinc ointment.It is known, however, to those skilled in the art that, along sore
Any fatty shape creme that edge provides liquid barrier can be used.
The fluid therapies preparation prepared by two kinds of components is coated on therapentic part (such as sore or ulcer).As described above,
Fluid, the preferably denseness with liquid gel can be had by treating preparation, and the preparation for the treatment of can automatically be spread over
It so that the surface is completely covered on the surface of sore, ulcer or its similar conditions, while will not flow away, and provide from area for treatment
The function of moistening.The fluid therapies preparation is shortly before it is coated, by the way that two kinds of described components are mixed to prepare.
Then, the treatment preparation is cultured a period of time to allow said preparation to play effectiveness.The treatment preparation is
Through showing to realize effect after 30 seconds, therefore, said preparation should be at least cultured 30 seconds before being eliminated.
However, more preferable effect is had been illustrated with if said preparation is cultured a few minutes, should according to an embodiment
Treatment preparation is cultured 5 minutes to 10 minutes.According to an embodiment, the culture is carried out always up to small bubble and chlorine
The smell chlorine compound of activity (if used) occur after disappear again, this generally occurs in 5 minutes to 10 minutes, mostly
In the case of number in 5 minutes.Therefore, in most cases, above-mentioned the first reaction worked of preparation is treated at 5 minutes to 10
Completed in minute.
For many years, chloramines is had been used in the treatment in oral cavity with concentration mentioned above, and without report and this
The related indication for the toxic effect of human body.Any side effect (King is not shown for the toxicologic study of mucous membrane of mouth
CD, Stoudt MS.Toxicological evaluations of a chemical caries-removing agent.
Preclinical report, National patent development corporation, 1985；CarisolvTM
sensitizing potential in the guinea-pg：Magnusson＆Klingman test (G.P.M.T.),
Caroline Ruat, Chrysalis, Preclinical services-Europe.A2PU1478,1998；CarisolvTM-
Single application dermal irritation study in rat, Chrysalis, N 789/002-D-23,
1998；CarisolvTM--Test to evaluate irritation of the buccal mucosa in the
Guinea-pig, Chrysalis, 789/001,1998；Silica fumed CarisolvTM Acute Oral Toxicity
Study in the Rat.OECD Guideline no.420, Acute Oral Toxicity-fixed Dose method,
Bollen L.S.ScanTox, lab No 43241, Dk, 2001；Removing the necrosis(compress with
water or the like and drying))。
Therefore, when using preparation as described herein, wherein the primary halogenated amino acid of formation is used for the use described in text, in advance
Meter does not have big toxic action in use as described herein.
After the preparation is cultured, by such as using water or the like cleaning or wetting therapentic part so as to remove
Preparation is stated, is come alternately through area for treatment is wiped using compress/dressing/protection pad that is humidity and/or drying or the like
Remove the preparation.
It can also be used for effectively including silica, the compress of the material of super-strong moisture absorbing ability or activated carbon or protection pad
Clear up and/or remove unnecessary fluid and the part being decomposed.As described below, between in the treatment, compress or protection pad can also
It is used to cover therapentic part.
If the need arises, above-mentioned steps can be repeated one or more times.
After the treatment, the therapentic part can be covered by dry compress/dressing/protection pad, wherein, smooth surface is against sore
Face is to avoid adhering on sore face, so that it heals.Applying including silica, the material of super-strong moisture absorbing ability or activated carbon
Cloth or protection pad can also be used.Covering with bandage or the like can also be employed, for example, especially for vein
The situation of varicose ulcer.
Then, above-mentioned step (treatment) can be repeated, if for example, be necessary, once in a week, repeat 1 to 3 time or
More.
Between in the treatment, protection preparation can also be coated on the therapentic part, it is suitable to provide therapentic part
When moist environment, while the also healing at stimulation therapy position.
Described protection preparation can be creme or colloid substances (such as alcogel).It can include glycerine, cholesterol, stone
Wax, propylparaben and methyl p-hydroxybenzoate, polyethylene glycol (PEG), vaseline, tristerin, dimension life
Plain A, vitamin D.The protection preparation can also be following preparation：>=99.5% absolute alcohol, >=99% 2- propyl alcohol, >=
99% n-butyl alcohol, glycerine (meeting USP test specifications), poly- (the acrylic acid M of acrylate/C10-13n130,000th, 95% 2-
Amino-2-methyl -1- propyl alcohol, lavender, vitamin D (detremin, drops).
It is being that the example of the protection preparation that in the market can obtain is i) containing vitamin D and alternatively vitamin A
Mano+ (comes from RLS Global AB companies)；And ii) with trade mark Aberela (come from Janssen-Cilag AB public affairs
Department) colloid substances or creme containing vitamin A sold, vitamin D can be added into colloid substances or frost containing the vitamin A
In agent.
Vitamin D is used to improve local immunity defence, because it is expected that simultaneously known vitamin D has stimulation.
Know that vitamin A stimulates vitamin D to penetrate into tissue and reaches the position of the stimulation immune defense of body.
Protection preparation is coated on therapentic part (i.e. sore, wound, ulcer or similar conditions), wherein the protection preparation covers
Lid therapentic part.Alcogel or the like will provide for protective layer, and the protective layer is formed after alcohol evaporation.
The protection preparation is the treatment after the treatment using the treatment preparation of two kinds of components and using two kinds of components
It is coated between the treatment of preparation, and is preferably applied after one or many treatments have been carried out, also, when therapentic part does not have
When having infection or almost not infecting and when granulation tissue is visible, surface and the therapentic part week of therapentic part (such as sore)
The health tissues enclosed flush.
It should be recognized that the invention is not restricted to embodiment that is described above and can illustrating in embodiment, more really
Saying those skilled in the art to will recognize that in the framework of appended scope of the claims with cutting can be carried out
A variety of changes and modification.For example, in view of preferable using being treatment for sore or fistula, therefore the preparation for the treatment of preparation
It can be used to for example preventing or treating otitis.
The description of embodiment, the background of embodiment and method of testing
As described above, sore and wound are common and make patient and society by heavy burden.Even if having, also seldom
Have it is known can effectively, for curing chronic sore, wound and the preparation of ulcer.Therefore the treatment takes a long time,
They also can not often cause to heal completely.In some cases, amputation is unique alternative treatment.
In the past, a variety of different preparations have been tested, and as described above, the solution such as containing N- chlorotaurines is
It is used for treatment (Waldemar Gottardi and the Markus NagI, N- of skin ulcer as antiseptic through being noted
Chlorotaurine, a natural antiseptic with outstanding tolerability, J Antimicrob
Chemother 2010；65：399-409).
As described above, few experimental evidences support any specific wound cleaning solution or technology to be used to oppress
Property ulcer and the shortage of evidence should cause the concern of health care provider.
Be necessary to probe into the preparation of the new treatment for being used for sore or similar conditions, the preparation provide the various sores for the treatment of,
The possibility of wound and ulcer.
Therefore, preparation of the present invention investigated for burning, skin sore, wound, the ulcer even treatment of fistula.Order
Surprisingly, following article will significantly be shown people, and these preparations are proved to be effectively in described treatment, wherein, example
Such as, sore, burn, ulcer and fistula can thoroughly be treated or removed from patient.The fact that should be noted is that some are more
Year suffers from the patient of sore, ulcer or fistula disease, is repeatedly treated using known formulations, but described sore, ulcer or fistula
Pipe can not be eliminated or treat.
In addition, the treatment is not related to any pain, and the preparation seems with the effect to relieve the pain.It is in fact, real
The object for applying example represents all to reduce pain at the beginning and among treatment in treatment.
However, the mixture of described component should not be applied to the newly-generated epidermal tissue of burnt degree, because implementing
Shown in example, this seems to cause pain reaction (see below described embodiment 7).
Preparation used in embodiment
Unless otherwise stated, before the treatment preparation used in Examples below will apply, by will be with
Lower component is mixed and prepared：The water-based NaOCl component comprising 1%-2% (by weight) of one volume and including for a volume
Amino acid：Lysine+glutamic acid+leucine (1:1:Total amino content of 1 relation, by weight 0.7%-0.8%), TiO2
(by weight 0.04%), NaCl (0.3%-0.6% by weight), Na-CMC (medium-viscosities；By weight
3%) and NaOH (being added into by weight, to adjust pH to 9.5-10.5) component.The medium-viscosity of carboxymethyl cellulose
It is defined as 400-800 (mPas).
In embodiment, by 1/2ml to 2ml every kind of component with 1:1 ratio is used in mixed way.
Before application, the final pH for treating preparation is 9.5 to 10.5.
PH passes through the Fiveeasy FE20- with supplementary electrode LE 420pH electrodes (VWR International AB)
Basic pH meters (VWR International AB) measure.At room temperature and pressure, every batch of mark for using 4,7 or 10 respectively
Quasi- cushioning liquid measures calibration curve.The sample volume of recommendation is 1ml, in triplicate for test, and use hydroxide
Sodium and/or hydrochloric acid regulation sample, using the requirement for meeting component pH (pH is 9.5 to 10.5).
It is being prepared by two kinds of components with the replacement content according to above-mentioned embodiment and with the pH
Preparation, which is also expected, provides the effect similar to particular treatment preparation used in embodiment.For example, the active chlorine compound
Can also be Ca (OCl)2Or KOCl, and described one or more amino acid can be the embodiment party of appended claim
Those amino acid mentioned in formula or aspect.
Treatment procedure and outcome evaluation
The method according to the invention utilizes two kinds of liquid components, when two kinds of liquid components combine and are applied to treatment
Region on when, cause the chemical reaction for generating primary halogenated amino acid.Component used and mixture are illustrated within a context.
In the following, it is described that general procedure used in embodiment.Any specific details and the program step deviateed
Suddenly illustrated in embodiments respectively.
Mixed component and obtained mixture, i.e., described treatment preparation, immediately (in several seconds, most one minutes
It is interior) it is applied on therapentic part (such as ulcer).By this way, there is provided described shape occurs after being contacted with therapentic part
Into the reaction of halogenated amino acid.The reaction of the generation is allowed to continue progress, so as to which thanatogenic tissue is separated with health tissues,
Decompose and/or destroy simultaneously bacterium.The mixture of solution form, which is left on area for treatment (such as ulcer) place, to be continued 5 minutes or more
It is short, wherein, the reaction cause that the smell of bubble and chlorine occurs and then disappeared in the formulation.In some cases, solution
Need to be retained more than 5 minutes, but be within 9 minutes most long incubation time.
Then area for treatment is rinsed with water.Then thanatogenic tissue and purulence easily can be eliminated at ulcer, without
Exert a force.If it is necessary, sore or similar conditions are alternatively cleaned using the protection pad of humidity.Needing solution being maintained at
In the case of in ulcer, such as in the case of burn, in order that solution is maintained in ulcer, fatty creme is coated to and defined
(line) on the skin of ulcer.Unless otherwise stated, fatty creme isIn some cases, fatty creme
It can also be coated or be coated in some cases, to protect the edge of sore between two treatments.
After bacteria removal, purulence and thanatogenic tissue, freshly prepd treatment preparation is applied to therapentic part (as burst again
Ulcer) on, and 5 minutes or shorter time are retained in therapentic part, to eradicate any bacterium.By using water cleaning and/or
The solution is removed using wetted protection pad.As long as in need, it is this to affected part apply two treatments preparation and with water with/
Or the treatment of protection pad removing treatment preparation is regularly repeated.What explanation was definite in each example repeats scheme.Cause
This, described program may include repeating treatment about once weekly, and initial stage is frequent, so as to remove all purulence and dead
Die tissue.
Between treatment, the ulcer is placed in the case of without any active treatment so that this is organized in
Do not have to heal in the case of any disturbing factor.
As described above, after the treatment between treatment, the therapentic part can be covered with protection creme or protecting colloid
Thing (such as alcogel).
In embodiment 1 below, as described below, after the treatment between treatment, using including vitamin D
Mano+ (comes from RLS Global AB).Mano+ is the alcogel containing glycerine, after treat several times, when wound does not have
When having infection or almost not infecting and when granulation tissue is visible, and the surface of wound and surrounding health tissue are (i.e. all
The skin enclosed) it is coated when flushing.After coating, the ethanol in preparation evaporates from protective layer.
Preferably, between the two treatments with after treatment, the therapentic part should be just by sterile, non-adhesive table
The protection pad protection that face is dried, and the protection pad is kept by gauze.In most embodiments, using the shield of this drying
Pad.
In addition, do not apply pressure, such as the preferable bandage of sealing, because in testing, this may appear to cause taut
Bacteria Culture in region with covering.
The treatment of sore, ulcer or fistula based on or be potentially based on following one or more evaluated：
- by using ruler or the like and the size of the sore of camera/photo measurement；
Erythema around-sore, measurement is from sore edge to the outer peripheral distance of erythema in terms of mm；
The appearance of-infection or inflammation chronic sore or any sign of wound, such as there is chamber groove；
- survey of patients of pain is lived through before treatment, during treatment and after treatment, by using known vision mould
Intend pain scores method (VAS), graded from 1 to 10 pair of pain, for example, wherein, 8 be violent pain；
Known bacterium (for example, before the treatment using culture or after treatment) in-test sore be present；With
The contrast images of-sore, described image are taken with after treatment before treatment；By contrast images, for example, by
It can be expressed out in the inflammatory reaction that infection triggers.
Treatments of the embodiment 1- by the sore of the foot of the patient of deficiency disorder (such as diabetes and circulatory disorders)
Object is the male of 74 years old, and it has long-term medical history and chronic alcoholism.
He suffers from diabetes, using tablet in treatment, and continues till now.He also suffers from the artery of blood circulation reduction
Sclerotic conditions.His Zeng Zhongfeng and heart failure is suffered from, heart failure described in diuretic therapy is used.Since he ten how old
Rise, he inhales 40 cigarettes daily.He is with osteoporosis and once fractures for several times.
Before 4 years, he is stuck by a traffic accident, his left foot and left leg, and he has to oneself from vehicle
Pull out, so as to cause the circulation of his left leg impaired.
In 2 years before accident, once broken out erysipelas for several times in his left leg.Over the past two years, he was in the pin of left foot first
There is the ulcer for being infected and being difficult to heal, no matter which kind for the treatment of he gives, and the ulcer also could not between toe and the second toe
Heal and dimensionally increase.He is subject to huge pain and treated using the anodyne of heavy dose, the analgesic
Medicine includes morphine.Heavy dose of antibiotic (Meda AB, 750mg 1x 3, and Ciprofloxacin, HEXAL A
S, 750mg 1x 3) also it is administered four months.In last year half, he has significantly reduced the amount drunk.He is
Through keeping (prompt) diabetic diet immediately.Because the artery of left leg is insufficient, left leg has been carried out in November, 2011
Asrteriectasia is performed the operation.The ulcer is cleaned weekly twice, and is used during ulcer is cleared up(Abigo
Medical AB) treatment.It is also shown that the pseudomonad of substantial amounts of two strains, the bacterial antibiotic be present in culture test
With high resistance.
Because the patient suffers from diabetic artery ulcer of foot, and the sign for not showing any improvement ulcer is treated,
The patient was suggested in 2 months 2012 carries out amputation in orthopaedics clinic.He obtains the reservation after six weeks.Diagnosis and treatment in orthopaedics clinic
Before, no matter using described program treatment and treatment preparation described above whether will cause improvement and in any way
Him is helped, he receives test.
In Fig. 1, the photo of the ulcer before being shown with treating any treatment of preparation.The ulcer be located at big toe and
Between second toe, about 2cm to 3cm is deep, has about 12 cubic centimetres of volume.The ulcer includes dead group of grey
Knit.Culture test, which is shown in ulcer, has substantial amounts of two kinds of pseudomonad strains, and the strains have the resistance to the action of a drug.
The subsequent patient is used preparation of the present invention, is treated according to treatment procedure as described herein, wherein, enter altogether
Go 13 times and treated.Hereafter the date for the treatment of, comment and result are illustrated.
From the results of view, it is obvious that the ulcer healing after 13 treatments, and by using described above
Component mixture treatment and during the treatment, the pain of patient is mitigated.
Fig. 2 shows the photo of the pin in final treatment, wherein, except unnecessary skin histology to be eliminated be present
And scab, the ulcer have healed.After final treatment, the patient been proposed in scab and periodically applied
Embodiment 1- is commented on and result
Treatment (2012-03-02, i.e. on March 2nd, 2012) for the first time
Ulcer situation：
Length：39mm
Width：14mm
The depth of ulcer before treatment：23mm
The depth of ulcer after treatment：30mm
Surface area：562mm3
Ulcer cumulative volume before treatment：12558mm3
Ulcer cumulative volume after treatment：16380mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：10/10
The pain (VAS scorings) that patient estimates during treatment：8/10
The brief description of leg：
Whole shank has erythema, and strong stench is given out from leg.Purulent exudate can also be observed.Skin
The chamber groove around ulcer below skin can be observed.
Fig. 1 shows the ulcer carried out using treatment preparation before first time treatment.
Result after treating for the first time
External force need not be applied in thanatogenic tissue, can easily remove thanatogenic tissue.Chemical reaction has resulted in dead group
Knitting becomes to be partially separated with health tissues.However, and not all thanatogenic tissue and purulence can be eliminated.After the treatment, due to
The removing of thanatogenic tissue part, the volume increase of ulcer.
Second for the treatment of (2012-03-06)
Ulcer situation：
Length：37mm
Width：12mm
The depth of ulcer before treatment：23mm
The depth of ulcer after treatment：26mm
Surface area：444mm3
Ulcer cumulative volume before treatment：10212mm3
Ulcer cumulative volume after treatment：11544mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：8/10
The pain (VAS scorings) that patient estimates during treatment：6/10
The brief description of leg：
Only pin still has erythema.There are still stench, but than few in the past.Ulcer seems to be full of thanatogenic tissue, but
The preparation of the primary coating present invention and after removing thanatogenic tissue, depth in treating for the first time without as increased much.Surface area
Reduce and during treatment, pain keeps reducing, and after the treatment, pain continues to reduce.
Result after second for the treatment of
The pain that object is subjected to is reduced, and ulcer becomes a little bit smaller.Less erythema be present, and most purulence and dead
Tissue is died can easily to be removed.After second is treated, without stench and compared with pre-treatment, ulcer is being defined
Skin exists under less chamber groove.
Third time treatment (2012-03-14)
Ulcer situation：
Length：36mm
Width：12mm
The depth of ulcer before treatment：23mm
The depth of ulcer after treatment：23mm
Surface area：360mm2
Ulcer cumulative volume before treatment：8280mm3
Ulcer cumulative volume after treatment：8280mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：3/10
The pain (VAS scorings) that patient estimates during treatment：0/10
The brief description of leg：
Erythema has been reduced to the border of ulcer.In the presence of the stench substantially reduced, and the amount of exudate is relatively low.
Result after third time treatment
All thanatogenic tissues are eliminated, and only a dot fester is still present.Patient is no longer subject to pain, can be with
Cut out any anodyne.The depth dimensions of ulcer is not further added by.
4th treatment (2012-03-21)
Ulcer situation：
Length：35mm
Width：10mm
The depth of ulcer before treatment：19mm
The depth of ulcer after treatment：19mm
Surface area：350mm2
Ulcer cumulative volume before treatment：6650mm3
Ulcer cumulative volume after treatment：6650mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：
Patient is subjected to 2/10VAS
The pain (VAS scorings) that patient estimates during treatment：
Patient is subjected to 0/10VAS
The brief description of leg：
It can be observed without erythema.Almost there is no stench.The amount of exudate is also reduced by, and less chamber groove can be seen
Observe.
Result after 4th treatment
Culture test display, before this treatment, only exists two pseudomonads being observed before any treatment
One bacterial strain of bacterial strain.However, the pseudomonad quantity before treatment is still very high, and after the treatment, the quantity of the pseudomonad
It is considerably reduced, but the same resistance to the action of a drug is still suffered to antibiotic.Patient can be walked with leg and pin.He no longer needs to take
Use antibiotic.After the treatment, some purulence are only existed.
5th treatment (2012-03-28)
Ulcer situation：
Length：32mm
Width：10mm
The depth of ulcer：15mm
Surface area：288mm2
Ulcer cumulative volume：4320mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：1/10
The pain (VAS scorings) that patient estimates during treatment：0/10
The brief description of leg：
There is no stench caused by ulcer.Almost there is no chamber groove, and there is no erythema.
Result after 5th treatment
Compared with before, it is observed that the exudate in ulcer significantly decreases.The dressing of ulcer now can be from
The matching protection pad of consolidation changes into loosely ventilative without the sterile protection pad of adhesive surface and using gauze.
6th treatment (2012-04-04)
Ulcer situation：
Length：29mm
Width：9mm
The depth of ulcer：13mm
Surface area：261mm2
Ulcer cumulative volume：3393mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：1/10
The pain (VAS scorings) that patient estimates during treatment：0/10
The brief description of leg：
Before invention formulation is applied, considerably less fester is observed.Observe without stench and not
To chamber groove.A small amount of juice is observed.
Result after 6th treatment
After receiving treatment, the patient made an appointment diagnosis and treatment in orthopaedics clinic originally, and determined to postpone the amputation to shank.
In addition, orthopedist requires that the patient should be treated weekly twice.
7th treatment (2012-04-13)
Ulcer situation：
Length：28mm
Width：8mm
The depth of ulcer：8mm
Surface area：224mm2
Ulcer cumulative volume：3393mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：1/10
The pain (VAS scorings) that patient estimates during treatment：0/10
The brief description of leg：
There is no erythema, chamber groove, stench, also a small amount of exudate.
Result after 7th treatment
This treatment from the people having neither part nor lot in by carrying out before, and this two people do not take the photo of ulcer, do not have yet
Have and do any record about result.Therefore, with reference to the 8th treatment.
8th treatment (2012-04-16)
Ulcer situation：
Length：24mm
Width：7mm
The depth of ulcer：8mm
Surface area：168mm2
Ulcer cumulative volume：1344mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：1/10
The pain (VAS scorings) that patient estimates during treatment：0/10
Result after 8th treatment
Ulcer seems thoroughly clean, and fresh red granulation tissue can be observed in the bottom of ulcer.
9th treatment (2012-04-19)
Ulcer situation：
Length：23mm
Width：6mm
The depth of ulcer：7mm
Surface area：138mm2
Ulcer cumulative volume：966mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：0/10
(VAS's pain that patient estimates during treatment scores：0/10
The brief description of leg：
The minimum growth of detectable pseudomonad.
Staphylococcus aureus starts to grow to minimum number.
Result after 9th treatment
Ulcer is covered with Mano+, to protect the region around ulcer.Because ulcer seems very clean, therefore determine to be somebody's turn to do
Patient only receives treatment once weekly, so as to promote ulcer to be healed in the case of no any interference.
Tenth treatment (2012-04-25)
Ulcer situation：
Length：22mm
Width：6mm
The depth of ulcer：6mm
Surface area：132mm2
Ulcer cumulative volume：792mm3
Pain
The pain (VAS scorings) estimated before treatment with patient after treatment：0/10
Result after tenth treatment
Need not be in the case of applying any external force in ulcer, the thanatogenic tissue of any be eliminated.After treatment, hold
It is continuous ulcer is covered with the Mano+ comprising vitamin D.
Tenth seance (2012-05-03)
Ulcer situation：
Length：18mm
Width：4mm
The depth of ulcer：4mm
Surface area：72mm2
Ulcer cumulative volume：216mm3
Pain
The pain (VAS scorings) estimated before treatment with patient after treatment：0/10
Result after tenth seance
Ulcer very little.After treatment, ulcer is persistently set to be covered with the Mano+ containing vitamin D.
Tenth Retreatment (2012-05-11)
Ulcer situation：
Length：12mm
Width：3mm
The depth of ulcer：2mm
Surface area：36mm2
Ulcer cumulative volume：72mm3
Pain
The pain (VAS scorings) estimated before treatment with patient after treatment：0/10
Result after tenth Retreatment
After treatment, ulcer is persistently set to be covered with the Mano+ containing vitamin D.The depth of ulcer is minimum, and ulcer seems
Healing completely.
Final treatment (2012-05-18)
Ulcer situation：
Heal
Pain
The pain (VAS scorings) estimated before treatment with patient after treatment：0/10
The brief description of leg:
Ulcer healing, Fig. 2 show the photo of the pin in final treatment, wherein, it is to be eliminated unnecessary except existing
Skin histology and scab outside, ulcer healing.
After applying treatment preparation is applied once, unnecessary skin can be peeled from ulcer once region after positioning.
Result after final treatment
Ulcer healing, and suggest keeping using vaseline in scab.
The treatment of embodiment 2- infective ulcers
The object is the female with osteoporosis and with fracture and malnutritive poor appetite of 86 years old
Property.She falls in March, 2011, on front side of her right leg of tumble injury, so as to result in the wound of leg.Then, the wound
Generation infection is simultaneously general red, causes pain.Therefore she has taken antibiotic750mg 1x3, totally 100.It is initially every
It clears up the wound, clears up weekly later twice.
The cleaning of wound and do not improve wound situation using the treatment of antibiotic, also, in fact, the wound in chi
Become slightly on very little big.Object refusal takes any antibiotic.
It is arteriosity ulcus cruris that the wound, which is diagnosed, and the ulcer has existed for eight months in this stage,
The pain that this period, i) objects were undergone is increased, ii) occur more exudates, and iii at ulcer) when object is used
When this leg is marked time and walked, difficulty increase.
Ensuing replacement therapy is amputation.Object requires other treatment means, and she agrees to and received use institute above
The program stated and the test treatment for the treatment of preparation.Her height 134cm, body weight 41kg.
Then, the patient is treated using treatment preparation described above, according to above-mentioned treatment procedure, wherein,
Treated three times altogether.Vaseline is used to define the edge of sore during treatment.Dry protection pad is between two treatments
Also it is used to cover ulcer.
Date, comment and the result for the treatment of are shown below.After third time is treated, wound healing, object is without further
Treatment.She is appeared in another event on March 14th, 2012, and ulcer healing has been identified.
Embodiment 2- is commented on and result
Treatment (2011-11-10) for the first time
Wound situation
Length 65mm
Width 35mm
The depth of wound：5mm
Surface area：2275mm2
Total ulcer volume：11375mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：9/10
The pain (VAS scorings) that patient estimates during treatment：5/10
The brief description of leg
Whole right leg is covered with erythema.Strong stench is given out from ulcer.Bacteria Culture display is present to Phenoxymethyl
There is drug-fast staphylococcus penicillin (fenoximetylpenicillin) and flucloxacillin.
Treatment results
Without applying any external force thereon, most thanatogenic tissue and fester can be eliminated, and in removing phase
Between, object does not suffer from any pain.Without using compression bandage.Compared with pre-treatment, the pain undergone after the treatment reduces.
Second for the treatment of (2011-11-17)
Wound situation
Length 40mm
Width 13mm
The depth of ulcer：2mm
Surface area：520mm2
Total ulcer volume：1040mm3
Pain
The pain (VAS scorings) that patient estimates before treatment：3/10
The pain (VAS scorings) that patient estimates during treatment：0/10
The brief description of leg
Erythema is limited in the region of wound circumference.The ability that object is walked using right leg is recovered.It was observed that ooze
The amount for going out thing is reduced, and less stench be present.
Treatment results
The depth of wound has fallen to 2mm, then removes faint yellow non-viable non-apoptotic cell and fester.Wound size significantly subtracts
It is small.
Third time treatment (2011-12-01)
Wound situation
Length：37mm
Width：10mm
The depth of wound：There is no depth, it is concordant with skin
Surface area：370mm2
Pain
The pain (VAS scorings) preceding and that patient estimates during treatment for the treatment of：0/10
Patient does not undergo any pain
The brief description of leg
Wound does not have depth in skin plane.In addition, without erythema, fester, necrosis and stench.
Treatment results
Wound prepares recovery from illness.
Final comment
Because wound has healed, Patient Detection without coming clinic again.She was due to other thing appearance (2012- later
03-14), it is able to observe that, the wound seems to have healed.
The treatment of the sore infected on embodiment 3- occiputs
Object is the healthy male of 80 years old, and he is without long-term drug therapy.He receives abdomen stock in July, 2010
Ditch hernia (ingual hernia) is performed the operation.Postoperative infection does not occur by wound in he.In October, 2011, he is kicked behind the door with pin, he
There occurs skin infection for the toe of the right second.He is used for the first time750mg 1x3 are treated ten days, are used1g x 3 are treated ten days.
On November 4th, 2011, he fell down, and caused his the head back side, i.e. wound occurs in occiput.He is sent to emergency ward
Checked.He has diameter about 30mm surface circular wound.On November 10th, 2011, the wound used
Descutan is cleared up, and uses Mei Pikang (mepilex) and love health skin (aquacel) wrapping.On November 11st, 2011, by
Aggravate in headache, he is sent to nearest hospital and carries out Cranial Computed Tomography (computed tomography) inspection.CT results are shown, without cranium
Internal haemorrhage or any fracture.Doctor finds no need for clearing up wound.
On November 11st, 2011, for patient, wound unusual pain, he appeared in clinic and carried out using upper
The test treatment for the treatment of procedure and treatment preparation described in text.
In this stage, infected exposed wound is suffered from patient's occiput, tests and determines such as standard culture, wound quilt
Streptococcus and staphy lococcus infection.He then using it is described above treatment preparation treated, in the treatment between, he does not wrap up
Wound, because wound, in his back of head, the head of a quilt, which is given out a contract for a project, to be enclosed, and there can not possibly be suitable active dressing above it.
The general procedure for the treatment of procedure as described above, and hindering including treatment preparation described above is coated to
In the incrustation occurred at mouthful.
It is described to treat about weekly, altogether twice.After three weeks, the sore heals completely.The date for the treatment of, comment
Shown below with result.
Embodiment 3- is commented on and result
Treatment (2011-11-14) for the first time
Wound describes
The wound is in occiput, diameter 50mm, there is brown and the thick scab turned to be yellow.Purulence is included below in scab in the wound
Liquid.There are erythema and edema in the region of wound circumference.
Pain
The pain (VAS scorings) of patient's estimation：7/10
The treatment does not cause any pain to patient.
After being treated, after fester and non-viable non-apoptotic cell is removed, patient is not by any pain.
Second for the treatment of (2011-11-21)
Wound explanation
The wound diameter 35mm of occiput, there is the thin scab of jaundice, and have a small amount of yellow fester.Erythema and edema are reduced.
Pain
The pain (VAS scorings) of patient's estimation：3/10
The treatment does not still cause any pain to patient；In fact, it reduces pain.Scab can easily be gone
Remove, and most of purulence can also be eliminated.
Third time treatment (2011-11-28)
Wound describes
The wound diameter 20mm of occiput.Fester is not present in wound.Not it was observed that erythema and oedema.Patient is not subjected to
Any pain.
Pain
The pain (VAS scorings) of patient's estimation：0/10
Comment
After the treatment, wound seems completely clean and seems to prepare healing.
Final comment
No longer treated.
The wound was examined on December 2nd, 2011, and it is dry to find it, and without any infection sign.Institute
Wound is stated to heal completely on December 14th, 2011.
The treatment of embodiment 4- amputation wounds
Object is the male with diabetes of 72 years old, once using tablet and insulin for treating diabetes.This is right
As due to previous miocardial infarction, also with renal failure, hypertension, heart failure, and due to previous cerebral infarction, losing
Cognitive function is lost.He also suffers from pulmonary tuberculosis.
The autumn in 2011, the object accesses Eritrea (Eritrea) and due to the related dysfunctional disease of diabetes
Disease he in local hospitalization.It is observed that small wound on first toe of his left foot.When come back to hometown Sweden when,
There is necrotic canken on first toe of his left foot.The week of necrotic canken one is cleaned for several times.
Percutaneous transluminal angio plasty (PTA) has been carried out at 2 months 2012.Whatever treatment, the gangrenosum acne
Ulcer dimensionally increases, and the object carries out amputation.Then the anterior first time amputation of left foot has been carried out.After amputation
Wound do not heal, and the object suffers from pressure ulcer at heel.Left leg is clipped in decision, this amputation
Carried out on April 7th, 2012.New amputation wounds do not heal and he is subject to the severe pain as caused by wound.His quilt
Regulation takes antibiotic750mg x 3 (on May 24th, 2012), but the treatment does not still improve his
Situation.
According to above-mentioned treatment procedure, test treatment then is carried out using above-mentioned treatment preparation for the object.To being at present
Only, treated three times altogether.
Date, comment and the result for the treatment of are shown below.It can be drawn from result：The necrotic canken is dimensionally
Reduce and seem to heal.
Embodiment 4- is commented on and result
Treatment (2012-05-28) for the first time
Ulcer describes
The ulcer area of dark-brown scab covering 75%.There are the fester and slough of yellow below scab.Also foul smelling
With oedema and purulent exudate.
Length：27mm
Width：15mm
Depth：5mm
Area：405mm2
Volume：2025mm3
Also aphtha is observed at middle part.
The treatment preparation is coated twice and is cultured every time 5 minutes, the fester and slough and thick scab
A part can be eliminated.The ulcer is wrapped up using sterile non-sticky protection pad is dried, and the protection pad is fixed using bandage.
Bacteria Culture shows to produce the E.coli ESBL (ultraphotic spectrum beta-lactamase) of resistance pattern, for R：Cephalo thiophene
Oxime, cefotaxime, TOB, Ciprofloxacin, piperazine dihydrochloride monohydrate/Tazobactam Sodium, S：TrimSulfa and A meter
Card star.
Second for the treatment of (2012-05-31)
Object has been laughed at and felt quite pleased, because he there is no any pain, he can be in sleeping at night.He says that he feels now
Obtain healthy and happy.
Ulcer describes
Dark-brown scab only covers 1/3 ulcer area, there is a small amount of fester and slough below scab.In addition, institute
State ulcer no longer easily bleeding.A small amount of stench and exudate also be present.
Length：24mm
Width：12mm
Depth：3mm
Area：228mm2
Volume：864mm3
Patient does not have pain during being reported in treatment, and still, he says that he can feel preparation in action.
The aphtha healing that early stage observes at middle part.
The treatment preparation is coated and cultivated 9 minutes, is then rinsed out with water, fester and gangrene are eliminated.Institute
State treatment preparation to be applied and cultivated 6.5 minutes for the second time, then rinsed out with water.The ulcer use is fixed with adhesive tape
Sterile non-sticky protection pad wrapping.
Third time treatment (2012-06-04)
Patient for treatment still feels quite pleased, because he does not have pain.
Ulcer describes
There is no scab to leave, and do not observe the thanatogenic tissue of fester and the lower position in ulcer.There is no stench, have
A small amount of exudate.
Length：20mm
Width：9mm
Depth：3mm
Area：180mm2
Volume：540mm3
Patient does not have pain during being reported in treatment.
It is described treatment preparation be coated twice, be cultured each time 5 minutes and cultivate terminate after rinsed out with water.Some
Fester and gangrene can be eliminated without any pain.The ulcer uses the dry non-sticky protection pad bag for being fixed with adhesive tape
Prick.
The treatment of embodiment 5- anal fistula
Object is the male of 38 years old, and he once suffers from the anal fistula several years.Anal fistula is to extend to the different of skin surface from rectum
Normal path.For anal fistula because the bacterium being present in rectum generally infects, this also causes the opening of fistula in turn.Anal fistula
Treatment is usually directed to the surgical operation combined with antibiosis extract for treating.
In current situations, object is treated using antibiotic and by surgical closure fistula.These are controlled
Treatment is unsuccessful and after the treatment, however it remains anal fistula.
The object then carries out test treatment using treatment preparation as described above, wherein, the preparation is injected into fistula
Manage and be allowed to stay in fistula.Astoundingly, it appears that seance is only needed, because the object leads to for seven days after the treatment
Know care institutions vibrations, the wound fistula heals, and is not necessarily to receive further treatment.
Embodiment 6- is located at the treatment of leg bottom and the infective ulcer on pin
Object is the women of 36 years old, and she is diagnosed with unknown rheumatic disease, and arteries inflammation.Should
Object has infective ulcer spherical at number on leg and pin, and the diameter of the ulcer changes between 20mm-40mm.She suffers from
Ulcer was more than 6 years.
The previously used wind resistance wet tablet of the object, i.e. Sendoxan are treated.
In addition, the ulcer is previously in rheumatism clinic (thayer Green Si Ka university (Sahlgrenska
University) hospital, Goteborg) it is cleaned twice daily.(Abigo Medical AB) is used to cleaning and burst
Ulcer.However, object still leaves fester and gangrene by strong pain and after treatment and cleaning.
Then overall treatment procedure as described above treated using the test of above-mentioned treatment preparation object.All scholars
Woods is also applied on ulcer edge, and the ulcer is covered between two treatments by dry protection pad.Controlled three times altogether
Treat.Comment and result are shown below.
Embodiment 6- is commented on and knotFruit
Treat for the first time
The treatment preparation of the existing preparation of the present invention, which is coated in ulcer, to be kept for 5 minutes, then, removes purulence and gangrene, without
Object can be made to feel any pain.
Pain
Pain grade VAS before treatment：8/10
Pain grade VAS after treatment：1/10
Second for the treatment of (after first time initial treatment 7 days)
Ulcer situation：
Ulcer diameter is had been decreased by 10mm-20mm.
Without the sign of gangrene, a small amount of fester be present.
After second for the treatment of coating：
The treatment preparation of the existing preparation of the present invention is coated in ulcer and kept for 5 minutes, subsequent fester removed easily and
Any pain is not caused to patient.The treatment preparation that ulcer and then the existing preparation of the present invention are rinsed with water is coated holding other 5
Minute to eliminate the possibility of any bacterium infection.Ulcer seems to prepare healing.
Pain
Pain grade VAS before treatment：2/10
Pain grade VAS after treatment：0/10
Third time treatment (7 days after second for the treatment of)
Ulcer situation：
Ulcer healing or the maximum gauge with 10mm completely.
There is no the sign of fester.
Treatment
The treatment preparation is coated twice, and is cultured every time 5 minutes, to reduce the chance of any bacterium infection.
Pain
Pain grade VAS before treatment：0/10
Pain grade VAS after treatment：0/10
As a result
Treating for the third time latter week, all ulcer all heals.The fact that should be noted is which kind of no matter is given to control
Treat, these ulcer have existed for about 6 years.
The treatment of the infectious burns of embodiment 7-
Object is burnt in its back infectious, and size is 5.5cm x 6.6cm.
Object carries out test treatment using treatment preparation described above, overall according to above-mentioned treatment procedure, except this
Preparation is applied to burn above and has been cultured 3 minutes for the first time, is then cleared up and burnt with protection pad, applied preparation again and train
Support 2 minutes.Three days after treatment, object report reduces size undergone and burn and is reduced to 3cm x 4cm.New skin
Skin tissue can be seen and fester is not present.It is described treatment preparation applied again, but due to when treatment preparation with
During the skin histology contact newly formed, object experience pain, after two minutes, the treatment is interrupted.Eight days after the treatment, burn was cured
Close.
The pH and chloride content of the treatment preparation of embodiment 8- different times measurement
The treatment preparation is produced as described above.The chloride content and pH of the preparation after blending ingredients 1
Minute, 5 minutes, 10 minutes, 15 minutes and 60 minutes are measured.Chlorine test used is Cl21.005999.00
Spectroquant (Merck), and measured by spectrophotometer (Shimadzu 160) under wavelength 557nm, its
In the aliquot based on mixed solution determine effective chlorine.Under atmosphere of inert gases, using coming from Metler-Toledo's
PH meter and the electrode measurement pH for coming from Orion.As a result it is shown in following table, wherein min represents minute, and M represents molar concentration (i.e.
Mole every liter).
| Time (min) | pH | Available chlorine content (M) |
| 1 | 11.15 | 0.086 |
| 5 | 10.87 | 0.071 |
| 10 | 10.56 | 0.061 |
| 15 | 10.37 | 0.053 |
| 60 | 9.15 | 0.041 |
Embodiment 9- comes from the liquid of abscess using treatment preparation processing
Cotton applicator is soaked using the liquid in abscess, hereafter, as described below, they are exposed to treatment preparation.
Cotton applicator 1 is handled without using treatment preparation, is used as reference.
Cotton applicator 2.Treatment preparation is produced and is immediately coated (it is, being applied in 1 minute as described above
Apply) on cotton applicator 2.
Cotton applicator 3.After treatment preparation is produced and is allowed to stand for 5 minutes as described above, it is applied to cotton coating
On device 3.
Cotton applicator 4.After treatment preparation is produced and is allowed to stand for 15 minutes as described above, it is applied to cotton coating
On device 4.
All cotton applicators are sent to the type and quantity that laboratory Unilab is used to establish bacterium.Bacterial analysis, just
Carry out bacterial analysis after normal bacterial cell growth program, wherein, bacterial cell bacterium colony grows on agar plate, it is identified and
Counted.The amount of bacterium is classified as a large amount of, moderate or rare.Substantial amounts of bacterium is defined as being identified under the microscope simultaneously
More than 50 bacterium colonies on agar plate counted.Appropriate bacterium be defined as being determined and count under the microscope every
10 to about 50 bacterium colonies on individual agar plate.A small amount of bacterium be defined as being determined and count under the microscope in agar
It is less than 10 bacterium colonies on flat board.
As a result show, the sample mainly contains MRSA bacteriums (the i.e. golden yellow grape of methicillin-resistant in abscess liquid
Coccus).Cotton applicator 1 is found containing substantial amounts of MRSA bacteriums.Cotton applicator 2 is found thin containing a small amount of MRSA
Bacterium.Cotton applicator 4 is found containing the moderate MRSA bacteriums of content.Cotton applicator 3 be found containing content rare and
The bacterium of MRSA between moderate.
From this it can be concluded that the treatment preparation has bactericidal effect, and the bactericidal effect for the treatment preparation now prepared
It is significantly better than the bactericidal effect for the treatment preparation that a period of time has been stood before use.
Embodiment-conclusion
The treatment preparation of the present invention as described above has been shown to dissolving thanatogenic tissue and being capable of eliminating bacteria
Without damaging health tissues.
Wound, ulcer and anal fistula in above example, in first time using in several weeks after the treatment for the treatment of preparation, it is cured
Close or heal, and seem that in the case of no antibiotic, this healing rate is faster.When ulcer and wound drying
Inviscid protection pad loosely wrap up, rather than when being wrapped up with the good bandage of sealing, healing cycle also seems to be contracted
It is short.The bandage with good seal seems to provide the environment (not shown) for Bacteria Culture on wound and ulcer.
For two objects with infective ulcer and wound, it carries out treatment for a long time using traditional treatment
And remaining sole therapy is exactly amputation, has been clearly illustrated, preparation of the invention and treatment method are effective.Wound
Healing or heal and object reaction undergone pain is greatly reduced.
The sign being reduced is infected in local infection and propagation：Less pain, less edema, less stench, compared with
Few exudate, less chamber groove, less erythema and no sense of discomfort.This shows that ulcer and wound are cured in turn
Close.
Apparently, preparation of the invention can be used for bacterium, thanatogenic tissue and the fester for clearing up fistula, ulcer and wound.
When ulcer and clean wound, it enables immune system further to cure fistula, ulcer and wound, wherein, use the present invention
Preparation treatment seem strengthen agglutination.
Claims (42)
1. kit is used to manufacture sore, wound, ulcer or the fistula or ear for being used for preventing and/or treat non-mouth therapentic part
The purposes of scorching medicine, wherein, the medicine is treatment preparation, wherein, the kit includes
A. the first aqueous components, first aqueous components include one or more amino acid, one or more amino acid
Selected from alanine, arginine, asparagine, aspartic acid, glutamic acid, glutamine, isoleucine, leucine, lysine and/
Or valine, and
B. the second aqueous components, second aqueous components include the chlorine compound of activity, and the active chlorine compound is selected from
Cl2, chlorite, chlorate, perchlorate and/or hypochlorite compounds,
The pH of wherein described first aqueous components and/or second aqueous components is 9 to 11.5, in first aqueous components
In 30 seconds after being mixed together with second aqueous components and under room temperature and 1atm pressure, described treatment system
The pH of agent is 9 to 11.5.
2. purposes according to claim 1, wherein, second aqueous components include hypochlorite.
3. purposes according to claim 1, wherein, the pH of first aqueous components and/or second aqueous components
It is 10 to 11.5.
4. purposes according to claim 1, wherein, described prevention and/or treatment are imitated comprising analgesic effect and/or antibacterial
Fruit.
5. purposes according to claim 1, wherein, described sore, ulcer, fistula or otitis are chronic and comprising hairs
Scorching, infection and/or necrosis.
6. purposes according to claim 1, wherein, described active chlorine compound is in second aqueous components
Content is 0.5%-5% by weight.
7. purposes according to claim 1, wherein, described active chlorine compound is in second aqueous components
Content is 0.5%-3% by weight.
8. purposes according to claim 1, wherein, described active chlorine compound is in second aqueous components
Content is 1%-2% by weight.
9. purposes according to claim 1, wherein, described one or more amino acid include glutamic acid, leucine and
Lysine is made up of glutamic acid, leucine and lysine.
10. purposes according to claim 1, wherein, first aqueous components include the institute of 0.1%-1% by weight
The one or more amino acid stated.
11. purposes according to claim 1, wherein, first aqueous components also include colloidal substance.
12. purposes according to claim 11, wherein, the colloidal substance includes either polyethylene glycol, and/or carboxylic first
Base cellulose and/or polysaccharide material or their salt.
13. purposes according to claim 12, wherein, the salt is sodium carboxymethylcellulose.
14. the purposes according to claim 11 or 12, wherein, first aqueous components include 2%-4% by weight
The colloidal substance.
15. purposes according to claim 1, wherein, the kit includes：
A. the first aqueous components, first aqueous components include 0.1%-1% glutamic acid, leucine and bad ammonia by weight
Acid and by weight 2%-4% sodium carboxymethylcellulose, and
B. the second aqueous components, second aqueous components include 1%-2% sodium hypochlorite by weight.
16. purposes according to claim 1, wherein, mixed in first aqueous components and second aqueous components
In 30 seconds after being combined and under room temperature and 1atm pressure, the pH of described treatment preparation is 10 to 11.5.
17. purposes according to claim 1, wherein, the medicine is used to prevent and/or treat non-mouth therapentic part
Sore.
18. purposes according to claim 1, wherein, the medicine is used for the wound for preventing and/or treating non-mouth therapentic part
Mouthful.
19. purposes according to claim 1, wherein, the medicine is used to preventing and/or treating bursting for non-mouth therapentic part
Ulcer.
20. purposes according to claim 17, wherein, the sore is bedsore.
21. purposes according to claim 18, wherein, the wound is amputation wounds.
22. purposes according to claim 19, wherein, the ulcer is the ulcer of leg and/or foot.
23. purposes according to claim 19, wherein, the ulcer is diabetic foot ulcers.
24. purposes according to claim 1, wherein, the fistula is anal fistula.
25. purposes according to claim 1, wherein, the sore, wound or ulcer are burnt to be infectious.
26. kit is used to manufacture sore, wound, ulcer or the fistula or ear for being used for preventing and/or treat non-mouth therapentic part
The purposes of scorching medicine, wherein, the medicine is treatment preparation, wherein, the kit includes
A. the first aqueous components, first aqueous components include one or more amino acid, one or more amino acid
Selected from alanine, arginine, asparagine, aspartic acid, glutamic acid, glutamine, isoleucine, leucine, lysine and/
Or valine, and
B. the second aqueous components, second aqueous components include the chlorine compound of activity, and the active chlorine compound is selected from
Cl2, chlorite, chlorate, perchlorate and/or hypochlorite compounds,
The pH of wherein described first aqueous components and second aqueous components is 9 to 11.5.
27. treatment preparation be used for manufacture be used for prevent and/or treat non-mouth therapentic part sore, wound, ulcer or fistula or
The purposes of the medicine of otitis, wherein, the treatment preparation can be by with volume ratio 1:2 to 2:1 mixing following substances obtain：
A. the first aqueous components of one or more amino acid are included, one or more amino acid are selected from alanine, smart ammonia
Acid, asparagine, aspartic acid, glutamic acid, glutamine, isoleucine, leucine, lysine and/or valine；And
Second aqueous components of the halogen compounds b. comprising activity, the active halogen compounds are selected from Cl2, chlorite,
Chlorate, perchlorate and/or hypochlorite compounds,
Wherein, the pH of first aqueous components and/or water-based second component is 9 to 11.5, at described first water-based group
Divide in 30 seconds after being mixed together with second aqueous components and under room temperature and 1atm pressure, described treatment
The pH of preparation is 9 to 11.5.
28. purposes according to claim 27, wherein, second aqueous components include hypochlorite.
29. purposes according to claim 27, wherein, the volume ratio is 1:1.
30. purposes according to claim 27, wherein, mixed in first aqueous components and second aqueous components
In 30 seconds after being combined and under room temperature and 1atm pressure, the pH of described treatment preparation is 10 to 11.5.
31. purposes according to claim 27, wherein, described prevention and/or treatment include analgesic effect and/or antibacterial
Effect.
32. purposes according to claim 27, wherein, described sore, ulcer, fistula or otitis be it is chronic and comprising
Inflammation, infection and/or necrosis.
33. purposes according to claim 27, wherein, first aqueous components include 0.1%-1%'s by weight
Glutamic acid, leucine and lysine and by weight 2%-4% sodium carboxymethylcellulose；Also, described second water-based group
Subpackage is containing 1%-2% sodium hypochlorite by weight.
34. purposes according to claim 27, wherein, the medicine is used to prevent and/or treat non-mouth therapentic part
Sore.
35. purposes according to claim 27, wherein, the medicine is used to prevent and/or treat non-mouth therapentic part
Wound.
36. purposes according to claim 27, wherein, the medicine is used to prevent and/or treat non-mouth therapentic part
Ulcer.
37. purposes according to claim 34, wherein, the sore is bedsore.
38. purposes according to claim 35, wherein, the wound is amputation wounds.
39. purposes according to claim 36, wherein, the ulcer is the ulcer of leg and/or foot.
40. purposes according to claim 36, wherein, the ulcer is diabetic foot ulcers.
41. purposes according to claim 27, wherein, the fistula is anal fistula.
42. purposes according to claim 27, wherein, the sore, wound or ulcer are burnt to be infectious.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE1250891-7 | 2012-07-24 | ||
| SE1250891A SE536581C2 (en) | 2012-07-24 | 2012-07-24 | A kit for treating wounds or the like and a preparation and methods thereof |
| PCT/EP2013/064919 WO2014016157A1 (en) | 2012-07-24 | 2013-07-15 | Preparation for treatment of wounds and sores comprising hypochlorite and amino acids |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104619330A CN104619330A (en) | 2015-05-13 |
| CN104619330B true CN104619330B (en) | 2018-01-19 |
Family
ID=48783266
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380039773.4A Active CN104619330B (en) | 2012-07-24 | 2013-07-15 | The preparation comprising hypochlorite and amino acid for treat wound and sore |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US9999605B2 (en) |
| EP (2) | EP3299022A1 (en) |
| JP (1) | JP6169693B2 (en) |
| CN (1) | CN104619330B (en) |
| CA (1) | CA2879362C (en) |
| ES (1) | ES2657598T3 (en) |
| MX (1) | MX360207B (en) |
| SE (1) | SE536581C2 (en) |
| WO (1) | WO2014016157A1 (en) |
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| SE536581C2 (en) | 2012-07-24 | 2014-03-11 | Rls Global Ab | A kit for treating wounds or the like and a preparation and methods thereof |
| JP2016535044A (en) | 2013-10-29 | 2016-11-10 | ハイポ−ストリーム・リミテッド | Anti-inflammatory solution containing sodium hypochlorite |
| GB2519774A (en) * | 2013-10-29 | 2015-05-06 | Hypo Stream Ltd | Anti-inflammatory solution |
| RU2684415C1 (en) * | 2018-04-18 | 2019-04-09 | Федеральное государственное бюджетное образовательное учреждение высшего образования Кубанский государственный медицинский университет Министерства здравоохранения Российской Федерации, ФГБОУ ВО КубГМУ МЗ РФ | Method of powder wounds treatment |
| CN114555073A (en) * | 2019-09-19 | 2022-05-27 | Rls全球公司 | Preparation for removing and/or preventing infection related to staphylococcus epidermidis |
| RU2741954C1 (en) * | 2020-07-20 | 2021-02-01 | Государственное бюджетное учреждение здравоохранения "Научно-исследовательский институт - краевая клиническая больница N 1 имени профессора С.В. Очаповского" Министерства здравоохранения Краснодарского края (ГБУЗ "НИИ-ККБ N 1 им. проф. Очаповского" Минздрава Краснодарского края) | Method of treating local head wounds with osteonecrosis of skull bones |
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2012
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2013
- 2013-07-15 MX MX2015001019A patent/MX360207B/en active IP Right Grant
- 2013-07-15 EP EP17196425.7A patent/EP3299022A1/en not_active Withdrawn
- 2013-07-15 EP EP13736590.4A patent/EP2877188B1/en active Active
- 2013-07-15 ES ES13736590.4T patent/ES2657598T3/en active Active
- 2013-07-15 WO PCT/EP2013/064919 patent/WO2014016157A1/en active Application Filing
- 2013-07-15 JP JP2015523491A patent/JP6169693B2/en active Active
- 2013-07-15 CA CA2879362A patent/CA2879362C/en active Active
- 2013-07-15 US US14/416,718 patent/US9999605B2/en active Active
- 2013-07-15 CN CN201380039773.4A patent/CN104619330B/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2879362A1 (en) | 2014-01-30 |
| EP3299022A1 (en) | 2018-03-28 |
| US9999605B2 (en) | 2018-06-19 |
| CA2879362C (en) | 2020-09-22 |
| SE1250891A1 (en) | 2014-01-25 |
| CN104619330A (en) | 2015-05-13 |
| WO2014016157A1 (en) | 2014-01-30 |
| MX2015001019A (en) | 2015-04-08 |
| EP2877188B1 (en) | 2017-10-25 |
| MX360207B (en) | 2018-10-24 |
| EP2877188A1 (en) | 2015-06-03 |
| US20150174091A1 (en) | 2015-06-25 |
| JP2015522632A (en) | 2015-08-06 |
| ES2657598T3 (en) | 2018-03-06 |
| JP6169693B2 (en) | 2017-07-26 |
| SE536581C2 (en) | 2014-03-11 |
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